Schellenberg David, Kahigwa Elizeus, Sanz Sergi, Aponte John J, Mshinda Hassan, Alonso Pedro, Menendez Clara
Centre for International Health, Institut d'Investigacions Biomedicas August Pi i Sunyer, Hospital Clinic, Villarroel 170, Barcelona 08036, Spain.
Am J Trop Med Hyg. 2004 Oct;71(4):428-33.
We used a prospective, open-label randomized trial to evaluate two treatment regimens in Tanzanian children two months to four years of age presenting to a hospital with a packed cell volume (PCV) < 25%. Treatment was either standard (14 days of ferrous sulfate and an antimalarial) or extended (three months of ferrous sulfate and three antimalarial treatments). The prevalence of anemia was measured two weeks after completion of treatment and six months after recruitment. Two weeks after completing treatment, the prevalence of PCV < 33% was 58% in the standard treatment arm and 44% in the extended treatment group (P = 0.04), and the mean PCV was significantly higher in the extended treatment arm (32.1%, SD = 4.5% versus 30.8%, SD = 4.9%; P = 0.031). However, there was no difference in the prevalence of PCV < 25% in the first survey, and the benefits of extended therapy were only apparent six months after recruitment in children compliant with the extended treatment (odds ratio of PCV < 25% = 0.16, P = 0.06). Compliance was satisfactory in only 39% (82 of 209) of the children in the first week of treatment. Extending the duration of therapy and improving compliance may have health benefits for anemic children in malaria-endemic settings.
我们采用了一项前瞻性、开放标签随机试验，以评估两种治疗方案对坦桑尼亚2个月至4岁、因血细胞比容（PCV）<25%而住院的儿童的疗效。治疗方案分为标准治疗（14天硫酸亚铁和一种抗疟疾药物）或延长治疗（三个月硫酸亚铁和三次抗疟疾治疗）。在治疗结束两周后以及招募后六个月测量贫血患病率。治疗结束两周后，标准治疗组中PCV<33%的患病率为58%，延长治疗组为44%（P = 0.04），延长治疗组的平均PCV显著更高（32.1%，标准差=4.5%，而标准治疗组为30.8%，标准差=4.9%；P = 0.031）。然而，在首次调查中，PCV<25%的患病率并无差异，延长治疗的益处仅在招募后六个月在依从延长治疗的儿童中显现（PCV<25%的优势比=0.16，P = 0.06）。在治疗的第一周，只有39%（209名中的82名）儿童的依从性令人满意。延长治疗时间和提高依从性可能对疟疾流行地区的贫血儿童有益。
